CLINICAL TRIAL SUMMARY

MDACC Study No:2005-0366 (clinicaltrials.gov NCT No: NCT00469144)
Title:A randomized study of once daily IV Busulfan with Fludarabine with hemopoietic stem cell transplantation for AML and MDS
Principal Investigator:Richard E. Champlin
Treatment Agent:Antithymocyte Globulin; Busulfan; Fludarabine
Study Status:Terminated
Study Description:The goal of this clinical research study is to learn if giving busulfan in a
dose based on blood levels, along with a fixed (unchanging) dose of
fludarabine, is more effective and causes fewer side effects for AML or
myelodysplastic syndrome patients than the standard method of giving a fixed
busulfan dose based on body size, along with a fixed dose of fludarabine. The
safety of dosing based on blood levels will also be studied.

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Disease Group:Blood And Marrow Transplantation; Leukemia
Phase of Study:Phase III
Treatment Agents:Antithymocyte Globulin
Busulfan
Fludarabine
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:28 days
Supported By:N/A
Return Visit:up to daily for the first 100 days, every 3 months for one year, yearly
thereafter x 5 years
Home Care:none


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Physician Name:Richard E. Champlin
Dept:Stem Cell Transplantation and Cellular Therapy
For Clinical Trial Enrollment:713-792-8750
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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